Miconazole - Generic Drug Details

What are the generic sources for miconazole and what is the scope of patent protection?

Miconazole is the generic ingredient in nineteen branded drugs marketed by Janssen Pharma, Galt Pharms, Perrigo R And D, Medtech Products, Cosette, Actavis Mid Atlantic, L Perrigo Co, Insight Pharms, Perrigo, Taro, P And L, Teva, Teva Pharms, Actavis Pharma, Personal Prods, and Mylan, and is included in thirty-two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for miconazole. One supplier is listed for this compound.

Summary for miconazole

US Patents:	1
Tradenames:	19
Applicants:	16
NDAs:	32
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	31
Drug Prices:	Drug price trends for miconazole
What excipients (inactive ingredients) are in miconazole?	miconazole excipients list
DailyMed Link:	miconazole at DailyMed

See drug prices for miconazole

See drug sales revenues for miconazole

Recent Clinical Trials for miconazole

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ain Shams University	Phase 3
October 6 University	Phase 3
Hill Dermaceuticals, Inc.	Phase 3

See all miconazole clinical trials

Pharmacology for miconazole

Drug Class

Azole Antifungal

Medical Subject Heading (MeSH) Categories for miconazole

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP2C9 Inhibitors

Cytochrome P-450 CYP3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for miconazole

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A07AC	Imidazole derivatives
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

D01AC	Imidazole and triazole derivatives
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J02AB	Imidazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for miconazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	MICONAZOLE 3	miconazole nitrate	CREAM;VAGINAL	076773-001	Mar 2, 2005		OTC	No	No
Medtech Products	MONISTAT 3 COMBINATION PACK (PREFILLED)	miconazole nitrate	CREAM;TOPICAL, VAGINAL	021261-001	Feb 2, 2001		OTC	Yes	Yes
Medtech Products	MONISTAT 1 COMBINATION PACK	miconazole nitrate	CREAM, INSERT;TOPICAL, VAGINAL	021308-001	Jun 29, 2001		OTC	Yes	Yes
Teva	MICONAZOLE NITRATE	miconazole nitrate	CREAM;VAGINAL	074136-001	Jan 4, 1995		DISCN	No	No
Medtech Products	MONISTAT 3 COMBINATION PACK	miconazole nitrate	CREAM;TOPICAL, VAGINAL	021261-003	Jun 17, 2003		OTC	Yes	No
Actavis Pharma	MICONAZOLE NITRATE	miconazole nitrate	SUPPOSITORY;VAGINAL	073508-001	Nov 19, 1993	AB	RX	No	No
Perrigo	MICONAZOLE NITRATE	miconazole nitrate	CREAM;VAGINAL	074760-001	May 15, 1997		OTC	No	No

Expired US Patents for miconazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010	8,518,442
Janssen Pharma	MONISTAT	miconazole	INJECTABLE;INJECTION	018040-001	Approved Prior to Jan 1, 1982	3,717,655
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010	7,651,698
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010	6,916,485
Janssen Pharma	MONISTAT	miconazole	INJECTABLE;INJECTION	018040-001	Approved Prior to Jan 1, 1982	3,839,574

Miconazole Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Miconazole Nitrate

Market Overview

Miconazole nitrate, an antifungal medication, has been experiencing significant growth in recent years, and this trend is expected to continue through 2031. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth Projections

The global Miconazole Nitrate market has undergone a swift and substantial surge, with projections indicating sustained significant expansion from 2023 to 2031. The market size is expected to grow substantially, measured in USD million, across various segments such as type (oral, cream) and application (vaginal treatment, external skin treatment, oral treatment)[1][4].

Segmentation Analysis

By Type

The market is segmented into oral and cream forms. The cream form is widely used for external skin treatments and vaginal treatments, while the oral form is less common but still significant. The cream segment is expected to dominate the market due to its broader application range[1][4].

By Application

Miconazole nitrate is used in various applications, including vaginal treatment, external skin treatment, and oral treatment. Vaginal treatment is one of the largest segments, driven by the high prevalence of fungal infections such as vaginal candidiasis[1][4].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Asia-Pacific is expected to be a key growth region due to increasing healthcare expenditure and a large patient population[1][4].

Market Drivers

Several factors are driving the growth of the Miconazole Nitrate market:

Increasing Prevalence of Fungal Infections

The rising incidence of fungal infections, particularly in regions with poor hygiene and limited access to healthcare, is a significant driver. This increase in demand for antifungal treatments propels the market forward[1][4].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in emerging economies, have led to better diagnosis and treatment of fungal infections, contributing to market growth[1][4].

Growing Awareness and Consumer Behavior

Increased awareness about health and hygiene, along with changing consumer behavior towards seeking medical treatment for fungal infections, is also driving the market[4].

Market Restraints

Despite the positive growth trajectory, there are several restraints to consider:

Regulatory Challenges

Stringent regulatory requirements, particularly from bodies like the FDA, can increase the cost and time required for new generic drug approvals. This can affect the entry of new players and the overall market dynamics[3].

Competition from Generic Drugs

The generic drug market is highly competitive, and the entry of multiple generic versions of Miconazole nitrate can lead to price reductions and margin compression for existing players[3].

Competitive Environment

The Miconazole Nitrate market is highly competitive, with several key players:

Major Players

Companies such as Actavis, TARO, PERRIGO, G&W, NHWA, JIANGSU YUNYANG, SDM, and HUARUN are prominent in the market. These companies are profiled based on their product offerings and market-related factors[1].

Market Entry and Competition

More firms enter the market quickly in segments with greater expected rents. However, generic drug prices fall with the number of competitors, approaching long-run marginal costs when there are 8 or more competitors[3].

Financial Trajectory

Revenue and Growth Rate

The market is expected to see significant revenue growth, with a substantial CAGR during the forecast period from 2025 to 2031. The base year for calculations is 2023, and historical data from 2019 to 2023 provides a baseline for future projections[1][4].

Pricing Dynamics

Generic drug prices, including those of Miconazole nitrate, decline with the number of producers. Initially, prices can be 35% to 50% above long-run marginal costs but approach these costs as the number of competitors increases[3].

Regional Financial Performance

Asia-Pacific is expected to dominate the market financially, driven by a large patient population and increasing healthcare expenditure. Other regions, such as North America and Europe, will also contribute significantly to the market's financial performance[1][4].

Porter's Five Forces Analysis

Threat of New Entrants

The threat of new entrants is moderate due to regulatory barriers and the need for significant investment in research and development. However, the potential for high returns in the generic drug market attracts new players[4].

Bargaining Power of Suppliers

The bargaining power of suppliers is relatively low due to the availability of raw materials and the competitive nature of the supplier market[4].

Bargaining Power of Buyers

The bargaining power of buyers is moderate, as they have some flexibility in choosing between different brands and generic versions of Miconazole nitrate[4].

Threat of Substitute Products

The threat of substitute products is low, as Miconazole nitrate is a specific antifungal medication with limited substitutes for its applications[4].

Competitive Rivalry Among Existing Competitors

The competitive rivalry is high due to the presence of multiple players and the competitive pricing dynamics in the generic drug market[4].

SWOT Analysis

Strengths

• Established market presence of key players.
• High demand for antifungal treatments.
• Advancements in healthcare infrastructure.

Weaknesses

• Regulatory challenges.
• High competition leading to price reductions.
• Dependence on raw material suppliers.

Opportunities

• Growing awareness and consumer demand.
• Expanding into new geographical markets.
• Potential for new applications of Miconazole nitrate.

Threats

• Increasing competition from new entrants.
• Economic downturns affecting healthcare spending.
• Changes in regulatory policies.

Key Takeaways

• The Miconazole Nitrate market is expected to grow significantly from 2023 to 2031.
• The cream form dominates the market due to its broader application range.
• Asia-Pacific is a key growth region driven by increasing healthcare expenditure.
• Regulatory challenges and competition from generic drugs are significant restraints.
• The market is highly competitive, with several key players and a high threat of new entrants.

FAQs

Q: What are the main types of Miconazole nitrate products?

A: The main types of Miconazole nitrate products are oral and cream forms.

Q: Which application segment dominates the Miconazole Nitrate market?

A: The vaginal treatment segment is one of the largest application segments for Miconazole nitrate.

Q: What is the expected growth rate of the Miconazole Nitrate market?

A: The market is expected to grow significantly, with a substantial CAGR during the forecast period from 2025 to 2031.

Q: Who are the major players in the Miconazole Nitrate market?

A: Major players include Actavis, TARO, PERRIGO, G&W, NHWA, JIANGSU YUNYANG, SDM, and HUARUN.

Q: How does competition affect the pricing of Miconazole nitrate?

A: Generic drug prices, including those of Miconazole nitrate, decline with the number of producers and approach long-run marginal costs when there are 8 or more competitors[3].

Sources

1. Market Research Intellect, "Global Miconazole Nitrate Market Size, Scope And Forecast Report", December 2024.
2. Global Risk Community, "Setting up a Miconazole Manufacturing Plant: Project Report 2023".
3. Federal Trade Commission, "Generic Drug Industry Dynamics", February 2002.
4. Cognitive Market Research, "Global Miconazole Nitrate Market Report 2024 Edition".
5. HDFC Securities, "FDC Ltd. - Initiating Coverage", June 14, 2021.